Phase I and II trials constitute the first steps in the clinical development of promising therapies. Biostatistical assistance is not readily available to many clinical investigators charged with conducting these studies. The goal of this project is to provide a computer system tailored to the needs of phase I and II investigators. The system will: display the statistical properties of a selected study design; provide the facility to store and manage study data; and prepare reports analysis of study results. The system will tailor the last two functions according to the selected study design. Phase I of the project will entail implementation of: (1) the NCI standard (phase I design); (2) the continual reassessment method (CRM); and (3) the general multistage phase II design. As part of phase I of the STTR, we will investigate the feasibility of integrating pharmacokinetic modeling and other clinical trials designs into package. During phase I we will develop documentation of the theoretical aspects of study design and develop a tutorial for the system using data from two studies conducted by the Childrens Cancer Group. PROPOSED COMMERCIAL APPLICATION: Phase I and II studies are conducted by a large number of hospitals, academic departments, cancer centers and pharmaceutical companies. Because of the small number of cases needed, each institution will generally design and manage their own studies. While optimal choice of design and proper study monitoring are essential to ensure that as few human subjects as possible are given ineffective or excessively toxic doses, few investigators have the tools necessary to make a fully informed decision on the choices available. We believe this product will be enthusiastically welcomed by the clinical research community.